Intra-oral device and method

ABSTRACT

An intra-oral device includes a tongue shield aspirator, a bite member, a bite grip, and an evacuation tube. The tongue shield aspirator may include a tongue retractor portion and a cheek retractor portion, and may be an open, unitary, and/or flexible component made of position-memory material. The bite member includes a conduit which receives the tongue shield aspirator through one end and the evacuation tube through the opposite end. The free end of the evacuation tube is connectable directly to a HVE valve to aspirate fluid/debris from the mouth. The device may be positioned in the mouth by bending the distal (free) end of the tongue shield aspirator, inserting the bite member into the mouth first, followed by the tongue shield aspirator as the device is moved towards the patient&#39;s cheek, releasing the free end of the tongue shield aspirator, and having the patient bite down on the bite member.

RELATED APPLICATION DATA

This application claims priority from Provisional Application Ser. No.61/126,294, filed May 2, 2008, which is incorporated herein by referencein its entirety.

FIELD OF THE INVENTION

Aspects of embodiments of the present invention relate generally todental devices and methods and, more specifically, to devices andmethods for providing intra-oral operative isolation, fluid and debrisaspiration, and tongue and cheek retraction.

BACKGROUND OF INVENTION

During dental and similar or related procedures, the patient's oralcavity is continually being filled with debris and fluids, includingsaliva and water sprayed into the mouth. Moreover, depending on thespecific location of treatment, the patient's tongue and/or cheek aretypically in the operator's way. To address these issues, separatetongue retractors, cheek retractors, and fluid-aspiration devices havebeen introduced that generally function as separate and discretedevices. As such, the dentist will usually need the help of an assistantin order to benefit from the advantages offered by such multiplicity ofindependent devices.

In order to address this issue, multi-unit devices have been introducedthat combine two or more of the above-mentioned functionalities.Nevertheless, some of these devices have proven to be too cumbersome, asthey require, e.g., special attachment units and tools for connectingthe device to a vacuum unit. As a result, they are also quite expensiveto manufacture and purchase. In addition, some devices are very complex,as they require, for example, both high-volume and low-volume suctioningcapabilities, or an additional electrical connection. The latter createsnot only a bulkier device, but also safety-related issues that must bedealt with.

SUMMARY OF THE INVENTION

Embodiments of the invention are directed to an intra-oral devicecomprising an open tongue shield aspirator including a first layerhaving a posterior side, an anterior side, a proximal edge, a distaledge, a bottom edge, and a top edge, a second layer having a posteriorside, an anterior side, a proximal edge, a distal edge, a bottom edge,and a top edge, wherein the proximal edges of the first and secondlayers are substantially flush with each other, and the posterior sideof the second layer is connected to the anterior side of the first layerby a plurality of walls such that the first and second layers are spacedapart from one another and define therebetween an axial passageway, withthe passageway having a distal end that coincides with the secondlayer's distal edge and is configured to be directly exposed to apatient's oral cavity, and a hollow neck extending proximally from theproximal edges of the first and second layers and in fluid communicationwith the passageway, wherein the neck's proximal end constitutes thepassageway's proximal end.

The intra-oral device may include an evacuation tube having a first end,and a second end that is configured to be coupled directly to ahigh-volume evacuation (HVE) valve, and a bite member that is configuredto be disposed between the patient's upper and lower teeth. The bitemember may include a conduit such that, at a distal end of the conduit,the bite member is configured to detachably mate with the neck of thetongue shield aspirator and, at a proximal end of the conduit, the bitemember is configured to detachably mate with the first end of theevacuation tube, thereby providing fluid communication between the HVEvalve and the patient's oral cavity via the evacuation tube, conduit,and passageway.

Embodiments of the invention are also directed to an intra-oral devicecomprising a unitary tongue shield aspirator including a first layercomprising a proximal flap that is configured to retract a patient'stongue, a second layer spaced apart from the first layer by a pluralityof walls so as to define an axial passageway between the layers, withthe passageway being in direct communication with the patient's oralcavity, and the plurality of walls forming at least one upper channelextending at an angle from the passageway to a top edge of the secondlayer and at least one lower channel extending at an angle from thepassageway to the bottom edge of the second layer so as to provide fluidcommunication between the passageway and the patient's oral cavity, anda hollow neck extending proximally from the first and second layers andin fluid communication with the passageway.

The intra-oral device may include an evacuation tube that is configuredto be coupled directly to a high-volume evacuation valve, a bite memberhaving an oblique conduit such that, at its distal end, the conduit isconfigured to detachably receive the neck of the tongue shield aspiratorand, at its proximal end, the conduit is configured to detachablyreceive an end of the evacuation tube. In embodiments of the invention,a bite grip may be included, wherein the bite grip has an upper memberconfigured to fit over a top side of the bite member and engageable bythe patient's upper teeth and a lower member configured to fit over abottom side of the bite member and engageable by the patient's lowerteeth.

Additional aspects and features of embodiments of the invention aredescribed below and/or shown in the accompanying diagrams.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an assembled intra-oral device in accordance with anembodiment of the invention.

FIG. 2 is an exploded view of components of an intra-oral device inaccordance with an embodiment of the invention.

FIG. 3A is an exploded, perspective view of a bite member and a tongueshield aspirator in accordance with an embodiment of the invention.

FIG. 3B is an exploded, anterior view of the bite member and a tongueshield aspirator shown in FIG. 3A.

FIG. 3C is a lateral view of the bite member and tongue shield aspiratorshown in FIG. 3A.

FIG. 4A is a posterior view of a tongue shield aspirator in accordancewith an embodiment of the invention.

FIG. 4B is a top view of the tongue shield aspirator shown in FIG. 4A.

FIG. 4C is an anterior view of the tongue shield aspirator shown in FIG.4A.

FIG. 5A is an exploded, perspective view of a bite member and a tongueshield aspirator in accordance with an alternative embodiment of theinvention.

FIG. 5B is an exploded, anterior view of the bite member and tongueshield aspirator shown in FIG. 5A.

FIG. 5C is a lateral view of the bite member and tongue shield aspiratorshown in FIG. 5A.

FIG. 6A is an exploded, perspective view of a bite member and tongueshield aspirator in accordance with an alternative embodiment of theinvention.

FIG. 6B is an anterior view of the bite member and tongue shieldaspirator shown in FIG. 6A.

FIG. 6C is a lateral view of the bite member and tongue shield aspiratorshown in FIG. 6A.

FIG. 7A is an exploded, perspective view of a bite member and tongueshield aspirator in accordance with an alternative embodiment of theinvention.

FIG. 7B is an anterior view of the bite member and tongue shieldaspirator shown in FIG. 7A.

FIG. 7C is a lateral view of the bite member and tongue shield aspiratorshown in FIG. 7A.

FIG. 8 is a perspective view of a bite member in accordance with anembodiment of the invention.

FIG. 9 is a perspective view of a bite grip in accordance with anembodiment of the invention.

FIG. 10 is a perspective view of an evacuation tube in accordance withan embodiment of the invention.

FIG. 11 is a top view of an assembled intra-oral device in accordancewith an alternative embodiment of the invention.

FIG. 12 is a perspective view of the intra-oral device shown in FIG. 11.

FIG. 13 is an anterior view of the intra-oral device shown in FIG. 11.

FIG. 14 is a posterior view of the intra-oral device shown in FIG. 11.

FIG. 15A is a perspective view of a bite member in accordance with analternative embodiment of the invention.

FIG. 15B is a side view of the bite member shown in FIG. 15A.

FIG. 15C is a view from an opposite side of the bite member shown inFIG. 15B.

FIG. 16A is a top plan view of an opened bite grip in accordance with analternative embodiment of the invention.

FIG. 16B is a bottom plan view of the bite grip shown in FIG. 16A.

FIG. 17A is a perspective view of an evacuation tube in accordance withan alternative embodiment of the invention.

FIG. 17B is a side elevational view of the evacuation tube shown in FIG.17A.

FIG. 17C is an end view of the evacuation tube shown in FIG. 17A.

FIG. 18 is an anterior view of an assembled intra-oral device inaccordance with an embodiment of the invention.

FIG. 19 is an exploded view of components of the intra-oral device shownin FIG. 18.

FIG. 20A is a top perspective view of a bite member in accordance withan embodiment of the invention.

FIG. 20B is bottom perspective view of the bite member shown in FIG.20A.

FIG. 20C is a posterior view of the bite member shown in FIG. 20A.

FIG. 20D is a distal side view of the bite member shown in FIG. 20A.

FIG. 20E is a proximal side view of the bite member shown in FIG. 20A.

FIG. 21A is a top perspective view of a bite grip in accordance with anembodiment of the invention.

FIG. 21B is a bottom plan view of the bite grip shown in FIG. 21A.

FIG. 22A is a side elevational view of an evacuation tube in accordancewith an embodiment of the invention.

FIG. 22B is an end view of the evacuation tube shown in FIG. 22A.

FIG. 23A is an anterior view of a tongue shield aspirator in accordancewith an embodiment of the invention.

FIG. 23B is a posterior view of the tongue shield aspirator shown inFIG. 23A.

FIG. 23C is a top side view of the tongue shield aspirator shown in FIG.23A.

FIG. 24A is an anterior view of a tongue shield aspirator in accordancewith another embodiment of the invention.

FIG. 24B is a posterior view of the tongue shield aspirator shown inFIG. 24A.

FIG. 24C is a bottom side view of the tongue shield aspirator shown inFIG. 24A.

FIG. 24D is a back-end view of the tongue shield aspirator shown in FIG.24A.

FIG. 25A is an anterior view of a tongue shield aspirator in accordancewith another embodiment of the invention.

FIG. 25B is a posterior view of the tongue shield aspirator shown inFIG. 25A.

FIG. 25C is a back-end view of the tongue shield aspirator shown in FIG.25A.

FIG. 25D is a bottom side view of the tongue shield aspirator shown inFIG. 25A.

FIG. 25E is a perspective view of an assembled intra-oral device inaccordance with an embodiment of the invention.

FIG. 26A is a perspective view of a tongue shield aspirator inaccordance with another embodiment of the invention.

FIG. 26B is a bottom side view of the tongue shield aspirator shown inFIG. 26A.

FIG. 27A is an anterior view of an intra-oral device held between apatient's upper and lower teeth.

FIG. 27B shows the intra-oral device of FIG. 27A inside the patient'smouth, with the patient's cheek retracted.

FIG. 28A is an anterior view of a tongue shield aspirator in accordancewith another embodiment of the invention.

FIG. 28B is a top perspective view of the tongue shield aspirator shownin FIG. 28A.

FIG. 29A is an anterior view of a tongue shield aspirator in accordancewith another embodiment of the invention.

FIG. 29B is a posterior view of the tongue shield aspirator shown inFIG. 29A.

FIG. 29C is top perspective view of the tongue shield aspirator shown inFIG. 29A.

FIG. 30A is an anterior view of an intra-oral device held between apatient's upper and lower teeth.

FIG. 30B shows the intra-oral device of FIG. 30A inside the patient'smouth.

DETAILED DESCRIPTION

As described in more detail hereinbelow, embodiments of the presentinvention are directed to intra-oral devices used to aid dentists,hygienists, oral surgeons, other dental professionals, etc. (hereinafterreferred to as “operator”) in isolating the operative field, aspiratingfluids and debris while working in the mouth, and maintaining patientcomfort by holding the mouth open and protecting the tongue and cheek,thereby providing simultaneous intra-oral operative isolation, fluid anddebris aspiration, and tongue and cheek retraction.

FIG. 1 shows an assembled intra-oral device 1, and FIG. 2 shows anexploded view of components of a device 100, in accordance withembodiments of the present invention. As shown in FIGS. 1 and 2,embodiments of an intra-oral device may include four main components: abite member 10, a bite grip 20, an evacuation tube 30, and a tongueshield aspirator 40, 140.

FIGS. 1-7, e.g., show various tongue shield aspirators in accordancewith embodiments of the present invention. It is noted that any one ormore of the tongue shield aspirators described in the ensuing discussionmay be disposable. Moreover, any one or more of the tongue shieldaspirators may be made of non-latex and/or non-silicone material, andmay be adapted for manufacture in a range of sizes, including adult andpediatric sizes.

As shown in FIGS. 3A-3C, a posterior tongue shield aspirator 40 has afirst (proximal) flap 40 a, which is configured to retract a patient'stongue, and a second (distal) flap 40 b, which is configured to retracta patient's cheek. The first and second flaps are joined to one anotherat a transition section 49 such that, when viewed from the perspectivesshown in FIGS. 3A and 3B, the transition section 49 forms the narrowestsection of the tongue shield aspirator 40, thereby forming an isthmusbetween the flaps 40 a, 40 b. It is noted that, although the flaps 40 a,40 b are described herein as being “joined” at the transition section49, this is simply for ease of reference. In practice, any of the tongueshield aspirators described herein in accordance with the variousembodiments of the invention (e.g., the tongue shield aspirator 40) maybe manufactured as a one-piece, or unitary, component, or the two flaps40 a, 40 b may be manufactured separately, and then coupled to oneanother at the transition section 49.

The tongue shield aspirator 40 includes a longitudinal hollow lumen 41that is in fluid communication with a multiplicity of branches, orchannels, that may extend at an angle therefrom. More specifically, theproximal flap 40 a and/or the distal flap 40 b of the tongue shieldaspirator 40 may be formed from a first (posterior) layer 48 a and asecond (anterior) layer 48 b which are connected to, but spaced apartfrom, one another by transverse walls 48 c. As shown, e.g., in FIG. 3B,each set of two consecutive walls 48 c that are disposed above thelongitudinal lumen 41 forms an upper channel 42 which extends from thelongitudinal lumen 41 towards the top edge 40 c of the proximal flap 40a. Similarly, each set of two consecutive walls 48 c that are disposedbelow the longitudinal hollow lumen 41 forms a lower channel 43 whichextends from the longitudinal lumen 41 towards the bottom edge 40 d ofthe proximal flap 40 a. With this construction, the longitudinal hollowlumen 41 itself is formed as a passageway having intermittent boundarysections that are defined by the ends of the transverse walls 48 c thatare closest to the longitudinal lumen 41. In this way, the channels 42,43 provide a plurality of conduits for debris and fluid evacuation,thereby allowing for simultaneous aspiration of debris and fluid fromtop (palate of mouth) to bottom (floor of mouth), and through thelongitudinal lumen 41, during dental procedures.

It is noted that, while, in the embodiment of FIGS. 3A-3C, the tongueshield aspirator 40 includes a plurality of upper channels and aplurality of lower channels, this is by way of illustration only. Thus,a tongue shield aspirator in accordance with embodiments of theinvention may include one or more of each of the upper channel(s) 42 andlower channel(s) 43. In addition, the layers 48 a, 48 b and thetransverse walls 48 c may be made of flexible material so as to enableproper placement of the tongue shield aspirator in the patient's mouth.Thus, each of the walls 48 c is “transverse” in that it is generallyperpendicular to the inner surfaces of the first and second layers 48 a,48 b when the tongue shield aspirator is laid flat, but flexes alongwith the first and second layers 48 a, 48 b when the tongue shieldaspirator itself is flexed, e.g., for placement in the patient's mouth.

A tongue shield aspirator having the above-described construction may beconsidered an “open” tongue shield in the sense that the upper and loweredges of the tongue shield are open to, or in communication with, thepatient's oral cavity. Thus, with reference to FIGS. 3A-3C, for example,each upper channel 42 extends to and through the top edge 40 c of theproximal flap 40 a, wherein the proximal flap may be formed by theproximal portions of the posterior layer 48 a and the anterior layer 48b, and the top edge 40 c of the proximal flap may be formed by therespective top edges of the posterior layer 48 a and the anterior layer48 b. Similarly, each lower channel 43 extends to and through the bottomedge 40 d of the proximal flap 40 a, wherein the bottom edge 40 d isformed by the respective bottom edges of the posterior layer 48 a andthe anterior layer 48 b. In this way, each of the top edge 40 c and thebottom edge 40 d of the proximal flap 40 a is open along the entirety ofthe length thereof.

In embodiments of the invention, the upper opening defined by the spacebetween the top edges of the anterior and posterior layers, and thelower opening defined by the space between the bottom edges of theanterior and posterior layers may extend through an additional portionof the tongue shield aspirator. Thus, a tongue shield aspirator inaccordance with embodiments of the invention may be open through aportion or all of (the top and bottom edges of) the transition sectionbetween the proximal and distal flaps. Alternatively, the tongue shieldaspirator may be open through a portion or all of (the top and bottomedges of) the distal flap.

As described above in connection with the proximal flap 40 a, inembodiments of the invention, the distal flap 40 b may be formed by thedistal portions of the posterior layer 48 a and the anterior layer 48 b.In alternative embodiments, however, one or both of the proximal anddistal flaps may be formed by the respective portion of the posteriorlayer only. In some such embodiments, the anterior layer may excludesome or all of the proximal and/or distal portions thereof.

Returning to FIG. 3, the tongue shield aspirator 40 includes a neck 46having a transverse anterior opening 47. In the embodiments shown inFIGS. 2 and 3, the longitudinal hollow lumen (or passageway) 41 extendsfrom the transition section 49 through the neck 46 and to the anterioropening 47. As will be discussed hereinbelow, when assembled, the neck46 is received within a lateral orifice of a bite member (such as, e.g.,orifice 12 of bite member 10), such that the anterior opening 47 isaligned with an opening in an anterior face of the bite member. It isnoted that, in the embodiment shown in FIGS. 3A-3C, the transitionsection may represent a closed end of the passageway. However, inembodiments of the invention, the longitudinal lumen 41 and the channels42, 43 may extend through not only the first flap 40 a, but also atleast a portion of the second flap 40 b.

In embodiments of the invention, one or both of the flaps 40 a, 40 b mayinclude an internal wire mesh 44, thereby allowing the operator to moldthe tongue shield aspirator 40 as needed for appropriate fit in thepatient's mouth. In addition, as shown in FIGS. 2 and 3, one or more ofthe flaps 40 a, 40 b may include finger-like projections 45 on thebottom and/or top edge thereof, thereby creating a “one-size-fits-all”feature and providing a comfortable form-fitting seal within thepatient's mouth.

FIGS. 4A-4C show an alternative embodiment of the posterior tongueshield aspirator 240 having a first flap 240 a, a second flap 240 b,channels 242, 243 extending from a longitudinal lumen 241, and a neck246 defining a transverse anterior opening 247 therethrough. These, aswell as many other features of the tongue shield aspirator 240 resemblethose of the tongue shield aspirator 40 discussed immediately above.However, in contrast with the latter, the tongue shield aspirator 240may include finger-like projections 245 on only the first flap 240 a. Inaddition, the longitudinal hollow lumen 241 of the tongue shieldaspirator 240 extends from the anterior opening 247 to an outer edge 240e of the second flap 240 b. Depending on the specific application, sucha configuration may offer various advantages over the construction ofthe tongue shield aspirator 40 shown, e.g., in FIG. 3. In addition, theinclusion of a longitudinal lumen that extends through both flaps 240 a,240 b allows for a simpler, more optimized manufacturing process.

In certain applications, aspiration from the distal side of the secondflap 240 b (i.e., the side that includes the edge 240 e) may be eitherunnecessary and/or undesirable, as it may lead to loss of pressure(i.e., lower suctioning capability) through the channels 242, 243. Forthese applications, a compressible valve 248 may be included on theposterior side of the second flap 240 b. Thus, when the tongue shieldaspirator 240 is placed in a patient's mouth, with the second flap 240 bretracting the patient's cheek, the force that is applied between thepatient's cheek and the posterior side of the second flap 240 b issufficient to close the valve 248, thereby closing off an end of thelongitudinal lumen 241.

It is important to note that, for ease of manufacturing, the tongueshield aspirator 240 may be manufactured as a “flat” piece, i.e., asshown in FIG. 4. However, such depiction in connection with this, or anyother embodiments of the tongue shield aspirator discussed herein is byway of illustration, and not limitation. Moreover, regardless of whetherany given tongue shield aspirator is manufactured as a flat or arcuatecomponent, the tongue shield aspirator may be made of material that hasposition memory. In this way, in order to place the component into thepatient's mouth, the two flaps (e.g., 40 a and 40 b, or 240 a and 240 b)are first brought towards one another. This results in a generallyC-shaped tongue shield aspirator that is then inserted into thepatient's mouth as discussed in more detail hereinbelow. Once inserted,the operator releases the force that was previously applied to the twoflaps, at which point the first flap expands outwards (i.e., towards a180° angle) to retract the patient's tongue, and the second flap expandsoutwards to retract the patient's cheek. It is noted that, in someembodiments, e.g., those in which the tongue shield aspirator is not,and/or is not manufactured as, a unitary component, only certainportions of the component, such as, e.g., the transition section betweenthe first and second flaps may be made of material having positionmemory to provide the above-described functionality.

As noted, the primary function of the tongue shield aspirator is toaspirate from top (palate of mouth) to bottom (floor of mouth)simultaneously during dental procedures while, at the same time,retracting or shielding the tongue and cheek from the operator'sinstruments, aspirating fluids/debris from the operating site, andpreventing fluid/debris aspiration by the patient during dentalprocedures. To this end, embodiments of the tongue shield aspirator maytake on various shapes and configurations in order to accommodatedifferent dental procedural needs.

FIGS. 5A-5C show one alternative embodiment, in which an anterior tongueshield aspirator 50 has a single longitudinal hollow channel 53. Inpractice, this component may be used to aspirate from the posteriorsurfaces of upper (maxillary) and lower (mandibular) anterior teethsimultaneously while retracting or shielding the tongue from theoperator's instruments, aspirating fluids/debris from the operatingsite, and preventing fluid/debris aspiration by the patient duringdental procedures.

As shown in FIG. 5C, the tongue shield aspirator 50 has a generallycup-shaped, or trumpet-shaped, configuration when viewed laterally. Inaddition, when viewed anteriorly, the tongue shield 50 has aregularly-undulating periphery that may be described by a plurality oflobes 52 defining the anterior face 51 thereof. As before, thiscomponent has a neck 54 which, in this embodiment, extends posteriorlyfrom a posterior face of the tongue shield, and then bends 55 at about a90° angle, extending toward one side of the mouth.

The neck 54 defines a transverse anterior opening 56 therethrough. Thus,the longitudinal hollow channel 51 extends from an opening 59 in theanterior face 51, through the neck 54, and to the opening 56. Whenassembled, the neck 54 is received within a lateral orifice of a bitemember (such as, e.g., orifice 12 of bite member 10), such that theanterior opening 56 is aligned with an opening in an anterior face ofthe bite member. This allows the tongue shield aspirator 50 to aspiratelingual or posterior surfaces of anterior teeth during toothpreparation. More specifically, the cup-shaped surface is configured tocapture aerosol and debris as the operator prepares the teeth anteriorto the tongue shield. Although this component may be adapted formanufacture in a variety of sizes, it also includes a“one-size-fits-all” feature in that its periphery can be trimmed for amore precise fit in the patient's mouth.

FIGS. 6A-6C show a generally paddle-shaped surgeon's tongue shieldaspirator 60, which is configured such that, in use, an anterior edge 62thereof is oriented anteriorly, and a bottom edge 69 thereof ispositioned proximate the floor of the mouth. The tongue shield aspirator60 has a longitudinal hollow lumen 61 that is in fluid communicationwith a multiplicity of branches, or channels, that extend at an angletherefrom. As shown in FIG. 6C, one set of branches 67 extends from thelongitudinal lumen 61 to the anterior edge 62 of the tongue shield, andanother set of branches 68 extends from the longitudinal lumen 61 to theposterior edge 63 of the tongue shield. In addition, the longitudinallumen 61 itself extends to and through the bottom edge 69.

In this way, the longitudinal lumen 61 and the channels 67, 68 provide aplurality of conduits for debris and fluid evacuation, thereby allowingfor simultaneous aspiration of fluids/debris from the operating sitefrom side to side and the floor of the mouth during dental proceduresand oral surgery (e.g., tooth extractions). At the same time, the tongueshield aspirator 60 retracts and/or shields the lateral surface of thetongue from the operator's instruments while, at the same time,preventing fluid/debris aspiration by the patient during dentalprocedures.

The tongue shield aspirator 60 includes a neck 65 having a transverseanterior opening 66. As noted, in this embodiment, the longitudinalhollow lumen 61 extends from the bottom edge 69 through the neck 65 andto the anterior opening 66. When assembled, the neck 65 is receivedwithin a lateral orifice of a bite member (such as, e.g., orifice 12 ofbite member 10), such that the anterior opening 66 is aligned with anopening in an anterior face of the bite member.

In embodiments of the invention, the tongue shield aspirator 60 mayinclude an internal wire mesh 64, thereby allowing the operator to moldthe tongue shield aspirator as needed for appropriate fit in thepatient's mouth. Although this component may be adapted for manufacturein a variety of sizes, it does nevertheless include a“one-size-fits-all” feature, whereby the tongue shield may be trimmed toshorten its length or depth of placement into the floor of the mouth.This component may be disposable and may be made of material other thanlatex or silicone.

In yet another alternative embodiment, FIGS. 7A-7C show a generalanesthesia (GA) tongue shield aspirator 70. The GA tongue shieldaspirator 70 includes a cup 71 that may be a disposable component andmay be made of material other than latex or silicone. The cup 71 isjoined to a conduit 72 which extends substantially anteriorly from thecup 71, and then bends 73, at about a 90° angle, into a neck 74. In oneembodiment, the conduit 72 may be made of bendable and/or moldablematerial, such as, e.g., plastic, and may include ribs 76 that allow thelength of the conduit to be expanded or contracted as needed, therebyproviding a “one-size-fits-all” feature. Again, the GA tongue shieldaspirator 70 may be adapted for manufacture in a variety of sizes. It isalso important to note that, while the conduit 72 may be manufactured asa separate component and then joined, or coupled, to the cup 71, this isby no means a requirement of the invention. Thus, for example, the cup71 and conduit 72 may be manufactured as a unitary or integratedcomponent.

The conduit 72 defines therethrough a longitudinal lumen that extendsfrom an opening 75 in the cup 71 to a transverse anterior opening 77.Thus, when assembled, the neck 74 is received within a lateral orificeof a bite member (such as, e.g., orifice 12 of bite member 10), suchthat the anterior opening 77 is aligned with an opening in an anteriorface of the bite member. In this way, in use, the GA tongue shieldaspirator 70 may be configured to hold surgical gauze arranged as a“throat pack” and trap debris while aspirating fluid/debris. Inaddition, given that, during dental procedures in which the patient isplaced under general anesthesia, the patient's normal responses tofluid/debris in the throat area are suppressed, the GA tongue shieldaspirator is also configured to prevent fluid/debris aspiration by thepatient.

As noted previously, the tongue shield aspirator (e.g., any one of thetongue shield aspirators 40, 50, 60, 70, 140, 240, or those describedhereinafter) may be used in an intra-oral device in conjunction with abite member, a bite grip, and an evacuation tube, any one or more ofwhich may be made of disposable material (e.g., plastic). As will beevident from the ensuing discussion, the bite member is generallyconfigured to hold the upper and lower jaws separate during dentalprocedures and/or similar procedures that require intubation. As such,this component is fully symmetrical and capable of bilateral use in themouth. In addition, the bite member may be used independently of atongue shield aspirator or an evacuation tube.

In general, the bite member may be made of metallic material, and may beadapted for manufacture in a variety of sizes, including adult andpediatric sizes. Alternatively, the bite member may be made of othermaterials. In embodiments of the invention, the bite member maypreferably be made of an autoclavable material, including anautoclavable resin, such as, e.g., an amorphous thermoplasticpolyetherimide (PEI) available under the name ULTEM®. Generally, thebite member may be made of material, and in such a way, that whencoupled to a bite grip, allows the combination to be soft andcompressible between the upper and lower teeth in an elastic manner,thereby providing a spring-like quality. In embodiments, therefore, thebite member may be referred to as the bite spring.

As shown, e.g., in FIG. 8, in embodiments of the invention, a bitemember 10 may be a re-usable (autoclavable) component having an uppermember 14 and a lower member 16. The upper and lower members 14, 16 areconnected to an intermediate member 18 via respective connectionsections 15, 17 proximate a posterior end 18 b of the intermediatemember 18. The intermediate member 18 also includes a lateral orifice 12which, as discussed above, may accommodate therethrough a variety oftongue shield aspirators to assist the practitioner in a multitude ofdiffering procedures. In addition, the intermediate member 18 defines ananterior opening 19 through the anterior face 18 a thereof, foraccommodating an end of an evacuation tube such as, e.g., evacuationtube 30, 230 (see below).

FIG. 9 shows a bite grip 20 in accordance with an embodiment of thepresent invention. The bite grip 20 may generally be a disposablecomponent that is used to cover the upper member 14 and the lower member16 of the bite member 10, thereby cushioning the patient's teeth fromthe bite member. To this end, the bite grip 20 includes an upper member24 and a lower member 26 that are joined to one another by a verticalspine 28. As shown in FIG. 9, the upper member 24 includes opposingpockets 24 a, 24 b which are configured to receive, respectively, matingprotrusions 14 a, 14 b which project from the upper member 14 of thebite member 10. Similarly, the lower member 26 includes opposing pockets26 a, 26 b, which are configured to receive, respectively, matingprotrusions 16 a (not shown), 16 b which project from the lower member16 of the bite member 10.

In embodiments of the invention, the bite grip 20 may also serve as aretention feature for dental impression material if desired to obtain a“custom” fit to the patient's dental anatomy. The bite grip 20 may bemade of a non-latex and/or non-silicone material, and is adapted formanufacture in a variety of sizes, including adult and pediatric sizes.

The purpose of an evacuation tube is to provide fluid communicationbetween the dental chair high-volume vacuum hose and the tongue shieldaspirator via the bite grip/bite member combination so as to enableaspiration of fluids and/or debris during dental procedures. Thus, asdescribed more fully below, the evacuation tube extends from within thebite member and out for connection to the industry standard-sizedhigh-volume evacuation (HVE)—and solely the HVE—valve 99 at the dentalauxiliary unit. In embodiments of the invention, the evacuation tube maybe made of metallic material. Alternatively, the evacuation tube may bemade of other materials. In embodiments of the invention, the evacuationtube may preferably be made of an autoclavable material, including anautoclavable resin, such as, e.g., an amorphous thermoplasticpolyetherimide (PEI) available under the name ULTEM®.

FIG. 10 shows an evacuation tube 30 in accordance with an embodiment ofthe invention. As noted, the evacuation tube 30 may be a re-usable(autoclavable) component which, in embodiments of the invention, mayhave a “U”-shaped configuration, so as to form a “U tube”. Theevacuation tube 30 is affixed (i.e., removably attached) to the anteriorface 18 a of the bite member 10 via a locking mechanism wherein tworadial flanges 31, 33 extend from a first end portion 32 of theevacuation tube 30 and are adapted to rotate within two respectivemating sockets 11, 13 defined within the anterior face 18 a of the bitemember 10, thereby interlocking the evacuation tube 30 and the bitemember 10. In this way, the evacuation tube 30 is rendered inseparablefrom the bite spring 10 when pulled in an anterior direction. Inaddition, when locked, the first end portion 32 of the evacuation tube30 is in (fluid) communication with the transverse anterior orifice and,therefore, with the longitudinal hollow lumen, of a tongue shieldaspirator. When assembled, the connection between the evacuation tube 30and the transverse anterior orifice of the tongue shield aspiratorpreferably creates a seal such that no air, fluid, or debris leaks as ittravels through the longitudinal hollow lumen and into the evacuationtube.

With the above construction, the evacuation tube exits the patient'smouth anteriorly rather than laterally, thereby creating greater patientcomfort and increased operative area for the operator's hands andinstruments. As shown, the evacuation tube includes a first bend 34 anda second bend 36, such that its second end 38 may then be attached tothe HVE valve 99. See also FIGS. 1 and 2. As shown in these Figures, theevacuation tube 30, and indeed, the overall intra-oral device 1, 100,may be used bilaterally in the mouth.

FIGS. 11-14 show an intra-oral device 200 in accordance with analternative embodiment of the invention. As shown, the device 200includes the same overall components that were discussed above, namely,a bite member 210, a bite grip 220, a tongue shield aspirator 240, andan evacuation tube 230 that, at one end, is attached to a HVE valve 99.FIGS. 15-17 provide further details of these components.

As shown in FIGS. 15A-15C, the bite member 210 includes an upper member214 and a lower member 216, wherein the anterior edge 214 c of the uppermember 214 and the anterior edge 216 c of the lower member 216 arebeveled. In addition, as compared with the bite member 10, wherein theupper member 14 and the lower member 16 are connected to an intermediatemember 18 via respective connection sections 15, 17 proximate aposterior end 18 b of the intermediate member 18, in the embodimentshown in FIGS. 15A-15C, the connection sections 215, 217 extendanteriorly through at least the longitudinal midpoint of theintermediate member 218 so as to fill a portion of the space between theintermediate member 218 and the upper and lower members 214, 216. Asshown in FIGS. 12, 15B, and 15C, the intermediate member 218 includes alateral orifice 212 to allow insertion of a tongue shield aspirator intothe body of the intermediate member 218. However, in contrast with theembodiments shown in FIG. 1-8, the orifice 212 opens on only one side ofthe intermediate member 218, and is closed off on the opposite side 212a.

The bite grip 220 shown in FIGS. 16A and 16B includes an upper member224 that is connected to a lower member 226 via a spine 228; each of theupper and lower members includes respective pockets 224 a, 224 b and 226a, 226 b for receiving therein respective protrusions 214 a, 214 b and216 a, 216 b on the upper and lower members 214, 216 of the bite member210. In addition, at a respective anterior edge thereof, the uppermember 224 includes a lip 224 c, and the lower member 226 includes a lip226 c, wherein the former is configured to fit around the beveled edge214 c, and the latter is configured to fit around the beveled edge 216c, of the bite member 210. Moreover, each of the upper member 224 andthe lower member 226 includes, on its respective outer surface, shapedregions 229, which are adapted to serve as “molar” guides for a moresecure fit between the patient's upper and lower jaws.

FIGS. 17A-17C show an evacuation tube 230 having a first end portion232, a second end 238, and two radial flanges 231, 233 which extend fromthe first end portion 232 and are adapted to rotate within tworespective mating sockets defined within the anterior face 218 a of thebite member 210. In this embodiment, the evacuation tube 230 includes asingle bend 234. Nevertheless, given that, when assembled, the first endportion 232 is affixed (i.e., removably attached) to the anterior face218 a of the bite member 210, the evacuation tube 230 still exits thepatient's mouth anteriorly rather than laterally, thereby creatinggreater patient comfort and increased operative area for the operator'shands and instruments.

FIGS. 18-19 show an intra-oral device 300 in accordance with anotherembodiment of the invention. As shown, the device 300 includes the sameoverall components that were discussed above, namely, a bite member 310,a bite grip 320, a tongue shield aspirator 340, and an evacuation tube330 that, at one end, is attached to a HVE valve 99. FIGS. 20-23 providefurther details of these components.

As shown in FIGS. 20A-20E, the bite member 310 includes a top side 314and a bottom side 316, wherein the anterior edge 314 c of the top side314 and the anterior edge 316 c of the bottom side 316 may be beveled.In addition, the top side 314 and bottom side 316 of the bite member 310lie in divergent planes, i.e., respective planes that diverge from oneanother at an acute angle so as to accommodate a patient's mouth in theopen position. In this way, the patient's mouth may be maintained openat various angles depending on the actual position of the bite memberwhen placed in the mouth. For example, given the acute angle between thedivergent planes of the top side 314 and bottom side 316, the fatherback (i.e., posteriorly) in the mouth the bite member is placed, themore open (i.e., the larger the opening of) the mouth. Obviously, theextent of such opening will be limited by the patient's anatomy.

As shown in FIGS. 19 and 20, the bite member 310 includes a conduit 312to allow insertion of a tongue shield aspirator and an evacuation tubeinto the body of the bite member. However, in contrast with theembodiments described previously, the conduit 312 extends through thebite member 310 at an oblique angle with respect to the vertical. Thus,the conduit has a distal end 312 a that is coplanar with a distal side315 of the bite member 310 and is configured to matingly receive a neckof a tongue shield aspirator, and a proximal end 312 b that extendsthrough the corner that connects the bite member's proximal side 317 andanterior side (i.e., anterior face) 318 and is configured to receive anend of an evacuation tube. As will be described below, offsetting of theconduit—and, therefore, of the distal end 312 a thereof—at an obliqueangle decreases resistance to airflow through the tongue shieldaspirator-bite member combination.

As has been noted previously, the bite members described herein may begenerally made of material, and in such a way, that when coupled to abite grip, may create a spring-like quality. In this regard, the topside 314 of the bite member 310 includes cavities (or core-outs) 314 dthat allow for and/or enhance the spring effect when covered with anupper member of a bite grip. Similarly, the bottom side 316 of the bitemember 310 includes cavities 316 d that allow for and/or enhance thespring-like quality when covered with a lower member of a bite grip.

The bite grip 320 shown in FIGS. 21A and 21B is substantially identicalto the bite grip 220 shown in FIGS. 16A and 16B. Thus, as describedpreviously, the bite grip 320 includes an upper member 324 that isconnected to a lower member 326 via a spine 328. The upper member 324includes pockets 324 a, 324 b for receiving therein respectiveprotrusions 314 a, 314 b on the top member 314 of the bite member 310.Similarly, the lower member 326 includes pockets 326 a, 326 b forreceiving therein respective protrusions 316 a, 316 b on the bottommember 316 of the bite member 310. In addition, at a respective anterioredge thereof, the upper member 324 may include a lip 324 c, and thelower member 326 may include a lip 326 c, with the former beingconfigured to fit around the beveled edge 314 c, and the latter beingconfigured to fit around the beveled edge 316 c, of the bite member 310.Moreover, each of the upper member 324 and the lower member 326 mayinclude, on its respective outer surface, shaped regions 329, which areadapted to serve as “tooth” or “molar” guides for a more secure fitbetween the patient's upper and lower jaws.

FIGS. 22A and 22B show an evacuation tube 330 having a first end 332,which is configured for slideable insertion through the proximal end 312b of the bite member 310, and a second end 338, which is configured tobe removably coupled directly to a high-volume evacuation (HVE) valve.As shown, the evacuation tube 330 may include a single bend 334 so as tobe generally L-shaped, with an inner angle α approximately equal to100°. In embodiments of the invention, the angle α may be between about85° and about 110°.

Proximate its first end 332, the evacuation tube 330 may include aradial flange 333 which, in turn, includes one or more radialindentation(s) 335. In the illustrative embodiment shown in FIGS. 22Aand 22B, the radial flange 333 includes three such indentations, whichare circumferentially spaced apart at irregular intervals. As shown,e.g., in FIG. 20E, the bite member 310 may include one or more internal(radial) protrusion(s) 313 which extend radially inwards, towards thecentral axis of the conduit 312, and extend longitudinally from theproximal end 312 b of the conduit 312 towards its distal end 312 a. Inthe illustrative embodiment shown, the bite member 310 includes threesuch protrusions, which are also circumferentially spaced apart atirregular intervals, but disposed such that, in a given orientation, andonly in that orientation, the protrusions 313 will be aligned with theindentations 335 of the evacuation tube 330.

The above-described combination of indentation(s) and protrusion(s)provides a lock-and-key locking mechanism for maintaining the evacuationtube 330 in a longitudinally-locked, but rotatable relationship relativeto the bite member 310. In practice, in order to detachably secure theevacuation tube 330 to the bite member 310 when the latter is heldbetween a patient's upper and lower teeth (e.g., in the position shownin FIG. 20E), the indentations 335 are first lined up with theprotrusions 313, and the first end 332 of the evacuation tube 330 ismoved inwardly through the proximal end 312 b of the conduit 312. Oncethe edge 336 of the evacuation tube 330 has reached the protrusions 313,the evacuation tube 330 is rotated, either clockwise orcounter-clockwise, to lock the evacuation tube 330 with respect to thebite member 310. In order to remove the evacuation tube, theabove-described process is reversed, wherein the evacuation tube isturned until the indentations 335 are again aligned with the protrusions313, and then the evacuation tube is pulled outwardly.

In embodiments of the invention, the protrusions 313 and indentations335 may be positioned such that the evacuation tube 330 can be insertedinto, and removed from, the bite member 310 only when rotated in theanterior position. Thus, by way of example, FIG. 20E shows the positionof the bite member 310 as it would be held between a patient'sright-hand upper and lower teeth. The perspective of FIG. 20E istherefore that of one looking at the patient's right profile. Withreference to FIG. 18, the evacuation tube must be connected to the bitemember 310 shown in FIG. 20E such that, in use, the second end 338 ofthe evacuation tube points generally to the left of the diagram, i.e.,away from the patient's mouth. For ease of discussion, this may bereferred to as “Position 2”. However, given the placement of theprotrusions 313, the latter will be aligned with the indentations 335only when the evacuation tube 330 is oriented such that its second end338 points generally to the right of the diagram. For ease ofdiscussion, this may be referred to as “Position 1”. In practice,therefore, once the protrusions and mating indentations have beenaligned and the first end 332 of the evacuation tube is inserted intothe conduit 312, the evacuation tube 330 is rotated about 180° so as tobe placed in Position 2. Given that the evacuation tube may be separatedfrom the bite member only in Position 1, the lock-and-key mechanismensures that the evacuation tube will not detach from the bite memberduring use, even if the evacuation tube-HVE valve assembly happens to berotated by a few degrees, as long as the evacuation tube is not rotatedall the way back to Position 1. In addition, given the configuration ofthe conduit 312 and the evacuation tube 330, during use, the evacuationtube 330 exits the patient's mouth at the conduit's oblique angle,rather than laterally, and then bends at an angle α, thereby creatinggreater patient comfort and increased operating space for the operator'shands and instruments.

FIGS. 23A-C show a tongue shield aspirator 340 in accordance with anembodiment of the present invention. The tongue shield aspirator 340includes features that are similar to those described above inconnection with the tongue shield aspirators 40, 240 shown in FIGS. 3and 4. Specifically, the tongue shield aspirator 340 has a first(proximal) flap 340 a, which is configured to retract a patient'stongue, and a second (distal) flap 340 b, which is configured to retracta patient's cheek. The first and second flaps are joined to one anotherat a transition section 349 such that, when viewed from the perspectivesshown in FIGS. 23A and 23B, the transition section 349 forms thenarrowest section of the tongue shield aspirator 340, thereby forming anisthmus between the flaps 340 a, 340 b. As before, it is noted that,although the flaps 340 a, 340 b are described as being “joined” at thetransition section 349, this is simply for ease of reference. Inpractice, the tongue shield aspirator 340 may be manufactured as aone-piece, or unitary, component, or the two flaps 340 a, 340 b may bemanufactured separately, and then coupled to one another at thetransition section 349.

The tongue shield aspirator 340 includes a longitudinal hollow lumen(not shown, but substantially identical to the longitudinal hollow lumen41 shown in FIG. 3) that is in fluid communication with a multiplicityof channels that may extend at an angle therefrom. More specifically,the proximal flap 340 a and/or the distal flap 340 b of the tongueshield aspirator 340 may be formed from a first (posterior) layer 348 aand a second (anterior) layer 348 b which are connected to, but spacedapart from, one another by transverse walls 348 c (shown in phantom inFIG. 23A). As shown, e.g., in FIG. 23C, each set of two consecutivewalls 348 c that are disposed above the longitudinal lumen forms anupper channel 342 which extends from the longitudinal lumen towards thetop edge 340 c of the proximal flap 340 a. Similarly, each set of twoconsecutive walls 348 c that are disposed below the longitudinal hollowlumen forms a lower channel 343 which extends from the longitudinallumen towards the bottom edge 340 d of the proximal flap 340 a. Withthis construction, the longitudinal hollow lumen itself is formed as anaxial passageway having intermittent boundary sections that are definedby the ends of the transverse walls 348 c that are closest to thelongitudinal lumen. In this way, the channels 342, 343 provide aplurality of conduits for debris and fluid evacuation, thereby allowingfor simultaneous aspiration of debris and fluid from top (palate ofmouth) to bottom (floor of mouth), and through the passageway, duringdental procedures.

It is again noted that, while, in the embodiment of FIGS. 23A-C, thetongue shield aspirator 340 is shown to include a plurality of upperchannels and a plurality of lower channels, this is by way ofillustration only. Thus, a tongue shield aspirator in accordance withembodiments of the invention may include one or more of each of theupper channel(s) 342 and lower channel(s) 343. In addition, theposterior and anterior layers 348 a, 348 b and the transverse walls 348c may be made of flexible material so as to enable proper placement ofthe tongue shield aspirator in the patient's mouth. Thus, each of thewalls 348 c is “transverse” in that it is generally perpendicular to theinner surfaces of the posterior and anterior layers 348 a, 348 b whenthe tongue shield aspirator is laid flat (i.e., as shown in the figures)but flexes along with these layers 348 a, 348 b when the tongue shieldaspirator itself is flexed, e.g., for placement in the patient's mouth.

As discussed previously in connection with the embodiments of FIGS. 3and 4, a tongue shield aspirator having the above-described constructionmay be considered an “open” tongue shield in the sense that the upperand lower edges of the tongue shield are open to, or in communicationwith, the patient's oral cavity. Thus, with reference to FIGS. 23A-C,each upper channel 342 extends towards the open top edge 340 c of theproximal flap 340 a, wherein the top edge 340 c is formed by therespective top edges of the posterior layer 348 a and the anterior layer348 b in the region of the proximal flap 340 a. Similarly, each lowerchannel 343 extends towards the open bottom edge 340 d of the proximalflap 340 a, wherein the bottom edge 340 d is formed by the respectivebottom edges of the posterior layer 348 a and the anterior layer 348 bin the region of the proximal flap 340 a. In this way, each of the topedge 340 c and the bottom edge 340 d of the proximal flap 340 a is openalong the entirety of the length thereof. In embodiments of theinvention, the upper opening defined by the space between the top edgesof the anterior and posterior layers, and the lower opening defined bythe space between the bottom edges of the anterior and posterior layersmay extend through the transition section 349 (as shown, e.g., in FIG.23C), as well as at least a portion of the distal flap 340 b.

FIG. 23C also shows a hollow neck 346 that is symmetrical with respectto the planes of the posterior and anterior layers 348 a, 348 b. Thus,in contrast to the embodiments shown in FIGS. 3 and 4, where the necks46, 246 extend at an angle from the respective planes of the tongueshield aspirators 40, 240, the neck 346 of the tongue shield aspirator340 shares the central axis of the longitudinal passageway definedtherethrough. Thus, the passageway extends from a distal end 346 b,through the proximal flap 340 a, and through the proximal end 346 a ofthe neck 346. As such, the proximal end of the passageway coincides withthe proximal end of the hollow neck. In embodiments of the invention,the distal end 346 b of the passageway may be located at a point along alongitudinal portion of the proximal flap 340 a, the transition section349, or the distal flap 340 b.

With reference to FIGS. 18-20, the neck 346 is configured to be matinglyreceived through the distal end 312 a of the bite member's conduit 312.In this regard, on its posterior side, the neck 346 may include alongitudinal projection 344 that mates with a groove 311 defined withina wall of the conduit 312. Specifically, as shown, e.g., in FIGS. 20Aand 20D, the groove 311 starts from the distal end 312 a and extendslongitudinally through a portion of the conduit 312. Thus, whenassembling the device 300, the projection 344 aids in correctlyorienting the tongue shield aspirator 340 with respect to the bitemember 310. In addition, when assembled, the combination of theprojection 344 and the groove 311 prevents rotation of the tongue shieldaspirator 340. As such, in embodiments of the invention, the tongueshield aspirator mates with the bite member in a non-rotational, as wellas a non-pivotable, manner.

Referring back to FIGS. 23A-C, in embodiments of the invention, one orboth of the flaps 340 a, 340 b may include finger-like projections 345on the bottom and/or top edge thereof, thereby creating a“one-size-fits-all” feature and providing a comfortable form-fittingseal within the patient's mouth. Thus, in the embodiment shown, each ofthe posterior and anterior layers includes projections 345 on each ofits top and bottom edges in the region of the proximal flap 340 a, withthe posterior layer having a profile that extends beyond the profile ofthe anterior layer, i.e., the top and bottom edges of the posteriorlayer extend beyond the respective top and bottom edges of the anteriorlayer. Moreover, the tongue shield aspirator 340 may include alongitudinal stiffener 347 on the anterior layer 348 b to preventkinking when the tongue shield aspirator is flexed and/or bent forplacement within the patient's oral cavity.

It is also noted that the first end 332 of the evacuation tube 330 isconfigured to fit within the hollow neck 346 of the tongue shieldaspirator 340. Thus, when assembled, the tongue shield aspirator's neckreceives therein the first end 332 of the evacuation tube so as to forma friction fit within the bite member's conduit 312, thereby decreasingthe likelihood of leakage and improving stability of the assembleddevice. In connection with the assembled device, as mentionedpreviously, offsetting of the conduit—and, therefore, of the distal end312 a thereof—at an oblique angle decreases resistance to airflowthrough the tongue shield aspirator-bite member combination. This goalis also furthered by the symmetrical, rather than angled, placement ofthe neck 346 with respect to the planes of the posterior and anteriorlayers 348 a, 348 b.

FIGS. 24A-D show a tongue shield aspirator 440 in accordance with analternative embodiment of the invention. As shown in the Figures, thetongue shield aspirator 440 is substantially similar to the tongueshield aspirator 340 discussed immediately above. Thus, tongue shieldaspirator 440 is an open component having a first (proximal) flap 440 a,which is configured to retract a patient's tongue, a transition section449, a second (distal) flap 440 b, which is configured to retract apatient's cheek, and a longitudinal passageway 441 that is in fluidcommunication with one or more channels that may extend at an angle fromthe passageway.

The proximal flap 440 a and/or the distal flap 440 b of the tongueshield aspirator 440 may be formed from a first (posterior) layer 448 aand a second (anterior) layer 448 b which are connected to, but spacedapart from, one another by walls 448 c (shown in phantom in FIG. 24A).As shown, e.g., in FIGS. 24A and 24C, each set of two consecutive walls448 c that are disposed above the passageway forms an upper channel 442which extends from the passageway towards the top edge 440 c of theproximal flap 440 a. Similarly, each set of two consecutive walls 448 cthat are disposed below the longitudinal hollow lumen forms a lowerchannel 443 which extends from the longitudinal lumen towards the bottomedge 440 d of the proximal flap 440 a.

The tongue shield aspirator 440 also includes a hollow neck 446 that issymmetrical with respect to the planes of the posterior and anteriorlayers 448 a, 448 b, such that the passageway 441 extends from a distalend 446 b, through the proximal flap 440 a, and through the proximal end446 a of the neck 446. As such, the proximal end of the passagewaycoincides with the proximal end of the hollow neck. In embodiments ofthe invention, the distal end 446 b of the passageway may be located ata point along a longitudinal portion of the proximal flap 440 a, thetransition section 449, or the distal flap 440 b.

The hollow neck 446 is configured to receive therein the first end 332of the evacuation tube 310 so as to form a friction fit within the bitemember's conduit 312. In addition, on its posterior side, the neck 446may include a longitudinal projection 444 that mates with the groove311. The tongue shield aspirator 440 may also include a longitudinalstiffener 447 on the anterior layer 448 b to prevent kinking when thetongue shield aspirator is flexed and/or bent for placement within thepatient's oral cavity.

As with the embodiment shown in FIG. 23, the posterior layer 448 a mayhave a profile that extends beyond the profile of the anterior layer 448b, i.e., the top and bottom edges of the posterior layer extend beyondthe respective top and bottom edges of the anterior layer. However, incontrast with the tongue shield aspirator 340, the tongue shieldaspirator 440 has no projections (i.e., similar to projections 345) onthe posterior layer 448 a, and the anterior layer 448 b now includes acut-out pattern along at least a portion of each of its top and bottomedges in the region of the proximal flap 440 a. Specifically, withreference to FIG. 24A, each upper channel 442 has a lower end that is indirect fluid communication with the passageway 441, and an upper endtowards the top edge of the anterior layer 448 b. Similarly, each lowerchannel 443 has an upper end that is in direct fluid communication withthe passageway 441, and a lower end towards the lower edge of theanterior layer 448 b. In turn, the top edge of the anterior layer 448 bincludes an indentation 442 a proximate the upper end of one or more ofthe upper channel(s) 442, and the bottom edge of the anterior layer 448b includes an indentation 443 a proximate the lower end of one or moreof the lower channel(s) 443.

Thus, in the illustrative embodiment shown in FIG. 24A, there are threesuch indentations 442 a, 442 b on each of the top and bottom edges ofthe anterior layer 448 b in the region of the proximal flap 440 a.Together, the three top indentations 442 a comprise a top cut-outpattern, and the three bottom indentations 443 a comprise a bottomcut-out pattern, each of which aids in enhancing debris and fluidaspiration from the patient's oral cavity. It is noted that, inembodiments of the invention, each of the top and bottom edges of theanterior layer 448 b may include one or more such indentations, whichindentations may be disposed further (distally) along the tongue shield,e.g., in and/or around the transition section 449.

FIGS. 25A-D show an open tongue shield aspirator 540 in accordance withan alternative embodiment of the invention. As shown in the figures, thetongue shield aspirator 540 is substantially similar to the tongueshield aspirator 440 discussed immediately above, except for thefollowing differences. First, as shown in FIGS. 25A and 25D, theanterior layer 548 b does not extend as far distally as the posteriorlayer 548 a. Rather, in this embodiment, the anterior layer 548 b islongitudinally shorter than the posterior layer 548 a, such that thedistal edge 548 d of the anterior layer 548 b is located proximally tothe distal edge of the posterior layer 548 a (i.e., located proximallyto the distal edge of the distal flap 540 b).

The tongue shield aspirator 540 also includes a hollow neck 546 that issymmetrical with respect to the planes of the posterior and anteriorlayers 548 a, 548 b, such that the passageway 541 extends from a distalend 546 b, through the proximal flap 540 a, and through the proximal end546 a of the neck 546. As such, the proximal end of the passagewaycoincides with the proximal end 546 a of the hollow neck, and the distalend 546 b of the passageway coincides with the distal end 548 d of theanterior layer 548 b. Thus, in the embodiment shown in FIGS. 25A-25D,the tongue shield aspirator 540 is open in the sense that, in additionto the upper and lower edges of the tongue shield, the distal end of thepassageway is also open to, or in communication with, the patient's oralcavity. This provides various advantages, including enhanced fluid anddebris aspiration, as well as facilitated bending at or around thetransition section 549.

Second, in addition to the anterior longitudinal stiffener 547, thetongue shield aspirator 540 may also include a posterior longitudinalstiffener 545 on the back (i.e., posterior) side of the posterior layer548 a for added support, e.g., when the tongue shield aspirator isflexed and/or bent for placement within the patient's oral cavity. Inthe embodiment of FIG. 25, the anterior stiffener 547 is integral withthe neck 546, and has a distal end that coincides with the distal end ofthe anterior layer 548 b. The posterior stiffener 545 is also integralwith (a posterior side of) the neck 546, but extends longitudinally pastthe transition section 549, as shown in FIG. 25B.

As mentioned, the tongue shield aspirator 540 is substantially similarto the tongue shield aspirator 440. Thus, for example, the tongue shieldaspirator 540 may include one or more top indentations 542 a and one ormore bottom indentations 543 a. In addition, as shown in FIG. 25A, thedistal edge 548 d of the anterior layer 548 b and/or the distal edge ofthe anterior stiffener 547 may include a longitudinal indentation tofurther enhance debris and fluid aspiration from the patient's oralcavity.

FIG. 25E shows an intra-oral device 500 in accordance with thisembodiment of the invention. As shown, in addition to the tongue shieldaspirator 540, the device 500 includes the same overall components thatwere discussed above in connection with FIG. 18, namely, a bite member310, a bite grip 320, and an evacuation tube 330 that, at one end, isattached to a HVE valve 99.

FIGS. 26A-26B show an open tongue shield aspirator 640 in accordancewith an alternative embodiment of the invention. As shown in thefigures, the tongue shield aspirator 640 is substantially similar to thetongue shield aspirator 540 discussed above, except that the tongueshield aspirator 640 now includes a raised portion 648 e on the distalflap 640 b. Thus, as in FIGS. 25A and 25D, the anterior layer 648 b islongitudinally shorter than the posterior layer 648 a, such that thedistal edge 648 d of the anterior layer 648 b is located proximally tothe distal edge of the posterior layer 648 a (i.e., located proximallyto the distal edge of the distal flap 640 b). The tongue shieldaspirator 640 also includes a hollow neck 646 that is symmetrical withrespect to the planes of the posterior and anterior layers 648 a, 648 b,such that the passageway 641 extends from a distal end 646 b, throughthe proximal flap 640 a, and through the proximal end 646 a of the neck646. As such, the proximal end of the passageway coincides with theproximal end 646 a of the hollow neck, and the distal end 646 b of thepassageway coincides with the distal end 648 d of the anterior layer 648b. Thus, the tongue shield aspirator 640 is open to, or in communicationwith, the patient's oral cavity through the distal end of the passagewayas well as the upper and lower edges of the tongue shield.

Also, in addition to the anterior longitudinal stiffener 647, the tongueshield aspirator 640 may also include a posterior longitudinal stiffener645 on the back (i.e., posterior) side of the posterior layer 648 a foradded support. As before, the anterior stiffener 647 may be integralwith the neck 646, and has a distal end that coincides with the distalend of the anterior layer 648 b. The posterior stiffener 645 may also beintegral with (a posterior side of) the neck 646, and may extendlongitudinally past the transition section 649.

Moreover, the tongue shield aspirator 640 may include one or more topindentations 642 a and one or more bottom indentations 643 a. Inaddition, the distal edge 648 d of the anterior layer 648 b and/or thedistal edge of the anterior stiffener 647 may include a longitudinalindentation to further enhance debris and fluid aspiration from thepatient's oral cavity.

As shown in FIGS. 26A-26B, however, on its anterior side, the posteriorlayer 648 a includes a raised portion 648 e that, distally, may abut thedistal end of the distal flap 640 b. Proximally, however, the raisedportion 648 e may be shaped so as to guide fluid and debris towards thedistal end 646 b of the passageway 641. Thus, in the exemplaryembodiment shown in FIG. 26A, the proximal side of the raised portion646 e is shaped like a truncated triangle, such that, when placed in apatient's oral cavity, fluid and/or debris from a top side of the cavityis directed towards the passageway 641 along the Arrow “B”, while fluidand/or debris from a bottom side of the cavity is directed towards thepassageway 641 along the Arrow “A”. As noted, however, other shapes andconfigurations may also be used, so long as the proximal side of theraised portion 648 e helps guide fluid/debris towards the passageway641.

It is noted that, in embodiments of the invention, such as those shown,e.g., in FIGS. 23-24, the anterior stiffener (e.g., stiffener 347) mayextend distally from the anterior side of the hollow neck. In otherembodiments, however, the stiffener may be physically separate from theneck, may be comprised of a series of spaced-apart, smaller stiffeners,and/or may be disposed on the anterior layer at various points along thelongitudinal axis of the tongue shield aspirator. Similarly, in FIGS.25-26, e.g., the posterior stiffener (e.g., the stiffener 545) is shownto extend distally from the posterior side of the hollow neck. In otherembodiments, however, the posterior stiffener may be physically separatefrom the neck, may be comprised of a series of spaced-apart, smallerstiffeners, and/or may be disposed on the posterior layer at variouspoints along the longitudinal axis of the tongue shield aspirator.

FIGS. 27A and 27B show an intra-oral device 600 after placement within apatient's mouth. Specifically, FIG. 27A shows the placement of thedevice 600 and, more particularly, of the bite member-bite grip 310, 320combination between the patient's upper and lower jaws without showingthe patient's mouth or cheeks. FIG. 27B shows the latter and, as such,shows the distal portion of the distal flap 640 b in phantom, as thisportion is bent within the mouth so as to retract the patient's cheek.It is noted that, while FIGS. 27A and 27B, as well as the ensuingdiscussion in connection with methodology, are directed to theintra-oral device 600 and its constituent components, this is forillustrative purposes only, and the discussion may be equally applicableto one or more of the other intra-oral devices and/or componentsdescribed herein.

As has been noted previously, the intra-oral device 600 may be assembledby attaching an unused bite grip 320 to a sterilized bite member 310.The autoclavable components of the device, such as, e.g., the bitemember 310 and the evacuation tube 330 may be sterilized in steamautoclave at a (max) temperature of 134° C. Next, an unused tongueshield 640 is inserted into the distal end 312 a of the conduit 312 ofthe bite member, such that the proximal edges of the posterior andanterior layers 648 a, 648 b are flush with the distal side 315 of thebite member 310 (see, e.g., FIG. 20). A sterilized evacuation tube 330is then inserted into the proximal end 312 b of the conduit 312,ensuring that the evacuation tube is rotated so as to be in its mostanterior or forward position and such that the protrusions 313 arealigned with the indentations 335 of the evacuation tube 330. As theevacuation tube is inserted into the bite member, its distal end isconfigured to insert into the hollow neck 646 of the tongue shield 640within the conduit 312. The evacuation tube 330 is then rotated to lockit in place. Finally, the proximal end of the evacuation tube isinserted directly into a HVE valve 99 (see, e.g., FIG. 25E).

Once assembled, the intra-oral device 600 may be inserted into thepatient's oral cavity. Prior to doing so, however, water may be sprayedon the posterior side of the tongue shield aspirator (i.e., the sidethat will be in contact with the patient's tongue so as to retract it)to lubricate it. To insert the intra-oral device, the bite member-bitegrip combination is positioned toward the center of the patient's mouth,and then gently inserted and moved towards a lateral position—which may,e.g., be performed with a curling, or rotating motion—within the cavity,preferably in one smooth motion. Thus, in the illustrative example shownin FIG. 27, the bite member-bite grip combination is first positioned(outside the mouth) towards the center of the mouth. With the proximalside (i.e., the left side looking at the diagrams in FIGS. 27A and 27B)of the device held with one hand, the operator then gently bends thedistal side, such that the distal flap 640 b curls outwards from theplane of the page in FIG. 27.

With the patient's mouth open, the bite member-bite grip combination isthen inserted into the mouth and moved towards the left of the diagramsin FIG. 27, until it reaches the space between the upper and lowerteeth. After the bite member-bite grip combination has been insertedinto the mouth, and as it begins to be moved to a lateral positionwithin the mouth, the rest of the device—i.e., the proximal flap, thetransition section, etc., of tongue shield aspirator—follows, such that,by the time the bite member-bite grip combination is at the patient'steeth, the operator begins to release the bending pressure on the distalend of the tongue shield aspirator so as to enable it to become uncurledwithin the mouth.

In following the bite member-bite grip combination, as it enters themouth, the tongue retractor portion (e.g., the proximal flap 640 a) ofthe tongue shield aspirator folds as its top and bottom edges encounterthe incisal edges of the anterior teeth, thereby gently pressing thetongue into a retracted position. The bite member-bite grip combinationis now positioned behind the first mandibular bicuspid—on the rightquadrant of the patient's mouth in FIG. 27—and the transition section ispositioned distal to the last molar(s)—on the left quadrant of thepatient's mouth in FIG. 27. The distal flap 640 b is then released so asto uncurl and retract the patient's (left) cheek. With the device inposition, the patient is then asked to close gently and so as toposition the bite member-bite grip combination comfortably betweenmaxillary and mandibular teeth of the mouth's left quadrant. With theHVE valve having been assembled, as described above, prior to insertionof the device, the valve may now be turned on so that treatment may bestarted.

It is noted that FIGS. 27A and 27B illustrate the positioning of theintra-oral device 600 in the mouth so as to prepare an obstruction-freeoperative space on the left side of the patient's mouth. For work to beperformed on the right side of the patient's mouth, the same assemblyand insertion procedures as those described above would be followed,expect that, here, the evacuation tube-HVE valve combination would bepositioned to the right, and the distal flap 640 b to the left, side ofthe diagram shown in FIG. 27 and, upon insertion into the oral cavity,the bite member-bite grip combination would be moved to the right sideof the diagrams. No additional steps are required; as has been notedpreviously, the bite member is fully symmetrical, and the tongue shieldaspirator is symmetrical about its longitudinal axis and, as such,configured for bilateral use in the mouth.

As has been discussed previously, any one or more of the tongue shieldaspirators described in the present application may be adapted formanufacture in a variety of sizes, including adult and pediatric sizes.In addition, or in the alternative, any one or more of the tongue shieldaspirators described in the present application may include a“one-size-fits-all” feature, whereby the periphery of the posteriorlayer and/or the anterior layer of the tongue shield aspirator may betrimmed for a more precise fit in the patient's mouth. In this regard,it is important to note that the shapes and sizes, including therelative sizes, of the posterior and anterior layers and the proximaland distal flaps are not limited to those described or shown. Rather,these elements may take on various shapes and/or sizes.

Thus, for example, FIGS. 28A and 28B show a tongue shield aspirator 740according to an embodiment of the invention, wherein the anterior layer748 b and neck 746 of the tongue shield aspirator 740 are identical tothe anterior layer 648 b and neck 646 of the tongue shield aspiratorshown, e.g., in FIG. 26. However, the posterior layer 748 a is nowconfigured such that each of the proximal flap 740 a and the distal flap740 b is larger in size, and of a quasi-rectangular, rather than simplyan arcuate, shape. As in the embodiment shown in FIG. 26, the posteriorlayer 748 a may also include a raised portion 748 e on its distal flap740 b for helping direct debris and fluids toward the passageway 741. Inembodiments of the invention, the proximal and distal flaps may take onvarious shapes and sizes.

Similarly, in alternative embodiments, in addition to, or in place of,varying the shapes and/or relative sizes of the proximal and distalflaps, the above-mentioned “one-size-fits-all” feature enables not onlyperipheral trimming, but also shortening of the tongue shield aspiratorby cutting along a line that is generally perpendicular to its thelongitudinal axis and is positioned proximally to the tongue shield'sdistal end. Thus, for example, FIGS. 29A-29C show a the tongue shieldaspirator 840 that has been trimmed, or cut, so as to include a proximalflap 840 a only.

As shown, the tongue shield aspirator 840 includes all of the elementsof, e.g., the tongue shield aspirator 640 shown in FIGS. 26 and 27,except that it has been cut proximally to the distal end of the anteriorlayer 648 b. Thus, although the anterior layer 848 b of the tongueshield aspirator 840 still includes a cut-out pattern along at least aportion of its top and bottom edges, it no longer includes alongitudinal indentation at its distal edge. The tongue shield aspirator840 does, however, still include a hollow neck 846 which has alongitudinal projection 844 on its posterior side and is in fluidcommunication with the passageway 841, an anterior stiffener 847, aposterior stiffener 845, walls 848 c, etc. It should be noted that thetongue shield aspirator may be trimmed along different points on itslongitudinal axis. Thus, for example, the tongue shield aspirator may becut at the distal end of the passageway, or at a point along thetransition section, etc.

FIGS. 30A and 30B show placement of the tongue shield aspirator 840within a patient's mouth. As can be seen, this is substantiallyidentical to the diagrams shown in FIGS. 27A and 27B, except that thetongue shield aspirator no longer includes a distal flap for retractingthe patients' (left) cheek. As discussed in connection with FIG. 27, inorder to prepare an operative space on the right side of the patient'smouth, the same assembly and insertion procedures as those describedabove would be followed, expect that, here, the evacuation tube-HVEvalve combination would be positioned to the right, and the distal endof the proximal flap 840 a to the left, side of the diagram shown inFIG. 30.

It is also important to note that one or more of the componentsdiscussed in the instant application may be adapted for use inconjunction with one or more of the other components described herein.Thus, for example, any one of the bite members discussed herein may beadapted for use with any one of the tongue shield devices discussedherein, and any one or more of the latter combination of components maybe adapted for use with, e.g., any one of the evacuation tubes discussedherein, and so on. In addition, while a specific type of HVE valve 99 isdescribed and shown in the diagrams, this is by way of illustration, andnot limitation. As such, any standard-sized (e.g., ½-inch diameter) HVEmay be used in conjunction with the components of the inventionsdescribed herein.

Also, as mentioned previously in connection with the tongue shieldaspirator 40, although the flaps of the tongue shield aspirator of thevarious embodiments of the invention are described herein as being“joined” at a transition section (e.g., transition section 49), this issimply for ease of reference. In practice, any of the tongue shieldaspirators described hereinabove may be manufactured as a unitaryone-piece component, or the two flaps (e.g., flaps 40 a, 40 b) may bemanufactured separately, and then joined to one another at thetransition section.

While the description above refers to particular embodiments of thepresent invention, it will be understood that many modifications may bemade without departing from the spirit and scope thereof. Theaccompanying claims are intended to cover such modifications as wouldfall within the true scope and spirit of the present invention.

The presently disclosed embodiments are therefore to be considered inall respects as illustrative and not restrictive, the scope of theinvention being indicated by the appended claims, rather than theforegoing description, and all changes which come within the meaning andrange of equivalency of the claims are therefore intended to be embracedtherein.

1. An intra-oral device comprising: an open tongue shield aspiratorincluding: a first layer having a posterior side, an anterior side, aproximal edge, a distal edge, a bottom edge, and a top edge; a secondlayer having a posterior side, an anterior side, a proximal edge, adistal edge, a bottom edge, and a top edge, wherein the proximal edgesof the first and second layers are substantially flush with each other,and the posterior side of the second layer is connected to the anteriorside of the first layer by a plurality of walls such that the first andsecond layers are spaced apart from one another and define therebetweenan axial passageway, said passageway having a distal end that coincideswith the second layer's distal edge and is configured to be directlyexposed to a patient's oral cavity; and a hollow neck extendingproximally from the proximal edges of the first and second layers and influid communication with said passageway, wherein the neck's proximalend constitutes the passageway's proximal end; an evacuation tube havinga first end, and a second end configured to be coupled directly to ahigh-volume evacuation (HVE) valve; and a bite member configured to bedisposed between the patient's upper and lower teeth and defining aconduit therethrough, wherein, at a distal end of the conduit, the bitemember is configured to detachably mate with the neck of the tongueshield aspirator and, at a proximal end of the conduit, the bite memberis configured to detachably mate with the first end of the evacuationtube, thereby providing fluid communication between the HVE valve andthe patient's oral cavity via said evacuation tube, conduit, andpassageway.
 2. The device of claim 1, wherein the tongue shieldaspirator and the bite member are made of different materials.
 3. Thedevice of claim 1, wherein at least one of the bite member and theevacuation tube is made of autoclavable material.
 4. The device of claim3, wherein the bite member and the evacuation tube are made ofautoclavable resin.
 5. The device of claim 3, wherein said autoclavablematerial is an amorphous thermoplastic polyetherimide.
 6. The device ofclaim 1, wherein the tongue shield aspirator is made of flexiblematerial.
 7. The device of claim 6, wherein said material is a softthermoplastic elastomer.
 8. The device of claim 1, wherein the tongueshield aspirator includes a proximal flap configured to retract thepatient's tongue.
 9. The device of claim 8, wherein the tongue shieldaspirator further includes a distal flap configured to retract thepatient's cheek.
 10. The device of claim 8, wherein the proximal anddistal flaps are joined to one another at a transition section, saidtransition section being narrower than each of the flaps so as to forman isthmus therebetween.
 11. The device of claim 10, wherein the firstlayer is a unitary component.
 12. The device of claim 10, wherein theproximal flap and the distal flap are separate components and areindividually coupled to the transition section.
 13. The device of claim10, wherein at least one of the proximal flap, the distal flap, and thetransition section is made of position-memory material.
 14. The deviceof claim 8, wherein the distal flap includes a raised portion to directfluid towards the passageway's distal end.
 15. The device of claim 1,wherein the tongue shield aspirator is a unitary component.
 16. Thedevice of claim 1, wherein the second layer is longitudinally shorterthan the first layer, such that the distal edge of the second layer isproximal to the distal edge of the first layer.
 17. The device of claim1; said plurality of walls including two walls disposed above the axialpassageway so as to form an upper channel extending from the passagewaytowards the top edge of the second layer, and two walls disposed belowthe axial passageway so as to form a lower channel extending from thepassageway towards the bottom edge of the second layer, wherein theupper channel provides fluid communication between the passageway and anupper portion of the patient's oral cavity, and the lower channelprovides fluid communication between the passageway and a lower portionof the patient's oral cavity.
 18. The device of claim 17, furtherincluding at least three upper walls above the passageway, wherein eachset of two consecutive upper walls forms an upper channel, and at leastthree lower walls below the axial passageway, wherein each set of twoconsecutive lower walls forms a lower channel, so as to form amultiplicity of upper and lower channels that provide fluidcommunication between the passageway and the patient's oral cavity. 19.The device of claim 17, wherein each said channel extends at an anglewith respect to the axial passageway.
 20. The device of claim 17,wherein the upper channel has an upper end towards the top edge of thesecond layer, the lower channel has a lower end towards the lower edgeof the second layer, the top edge of the second layer includes anindentation proximate said upper end of the upper channel, and thebottom edge of the second layer includes an indentation proximate saidlower end of the lower channel.
 21. The device of claim 1, wherein thesecond layer's distal edge that coincides with the passageway's distalend includes a longitudinal indentation.
 22. The device of claim 1,wherein the tongue shield aspirator includes a longitudinal stiffener.23. The device of claim 1, wherein the tongue shield aspirator mateswith the bite member in a non-rotational, non-pivotable manner.
 24. Thedevice of claim 1, wherein a posterior side of the neck includes alongitudinal projection and the bite member's conduit includes a grooveto matingly receive said projection so as to prevent rotation of thetongue shield aspirator.
 25. The device of claim 1, wherein the tongueshield aspirator's neck is configured to receive therein the first endof the evacuation tube so as to form a friction fit within the bitemember's conduit.
 26. The device of claim 1, wherein the bite member hasa proximal side, a distal side, a top side, and a bottom side, andwherein the distal end of the conduit is coplanar with the bite member'sdistal side.
 27. The device of claim 26, wherein the conduit extendsthrough the bite member at an oblique angle.
 28. The device of claim 27,wherein the bite member has a posterior side and an anterior side, andthe conduit's proximal end extends through a portion of each of the bitemember's proximate and anterior sides.
 29. The device of claim 27,wherein the evacuation tube is approximately L-shaped such that, whencoupled to the bite member, it exists the patient's mouth at saidoblique angle and then bends posteriorly at an angle of between about85° and about 110°.
 30. The device of claim 26, wherein each of the bitemember's top and bottom sides defines a plurality of cavities therein.31. The device of claim 26, wherein said top and bottom sides lie inrespective planes that diverge from each other.
 32. The device of claim26, further including a bite grip having an upper member configured tofit over the bite member's top side and engageable by the patient'supper teeth and a lower member configured to fit over the bite member'sbottom side and engageable by the patient's lower teeth.
 33. The deviceof claim 32, wherein each of said upper and lower members of the bitegrip includes shaped regions for receiving the patient's teeth.
 34. Thedevice of claim 1, further including a locking mechanism to detachablysecure the evacuation tube to the bite member.
 35. The device of claim34, wherein the locking mechanism includes: a radial flange proximatethe first end of the evacuation tube and having one or more radialindentations; and one or more internal radial protrusions adjacent saidproximal end of the bite member's conduit, wherein the first end of theevacuation tube is longitudinally moveable within the conduit only whenthe one or more radial indentations are aligned with the one or moreinternal radial protrusions.
 36. An intra-oral device comprising: aunitary tongue shield aspirator including: a first layer comprising aproximal flap configured to retract a patient's tongue; a second layerspaced apart from the first layer by a plurality of walls so as todefine between said layers an axial passageway in direct communicationwith the patient's oral cavity, said plurality of walls forming at leastone upper channel extending at an angle from the passageway to a topedge of the second layer and at least one lower channel extending at anangle from the passageway to the bottom edge of the second layer so asto provide fluid communication between the passageway and the patient'soral cavity; and a hollow neck extending proximally from the first andsecond layers and in fluid communication with said passageway; anevacuation tube made of autoclavable resin and configured to be coupleddirectly to a high-volume evacuation (HVE) valve; a bite member made ofautoclavable resin and defining a conduit that extends therethrough atan oblique angle, wherein, at a distal end thereof, the conduit isconfigured to detachably receive the neck of the tongue shield aspiratorand, at a proximal end thereof, the conduit is configured to detachablyreceive an end of the evacuation tube; and a bite grip having an uppermember configured to fit over a top side of the bite member andengageable by the patient's upper teeth and a lower member configured tofit over a bottom side of the bite member and engageable by thepatient's lower teeth.
 37. The device of claim 36, wherein saidautoclavable resin is an amorphous thermoplastic polyetherimide, and thetongue shield aspirator and bite grip are made of a soft thermoplasticelastomer.
 38. The device of claim 36, wherein the tongue shieldaspirator is made of position-memory material.
 39. The device of claim36, wherein the first layer further comprises a distal flap configuredto retract the patient's cheek.
 40. The device of claim 39, wherein thedistal flap includes a raised portion on an anterior side thereof todirect fluid towards said passageway.
 41. The device of claim 36,wherein the top edge of the second layer includes an indentationproximate an upper end of the at least one upper channel, and the bottomedge of the second layer includes an indentation proximate a lower endof the at least one lower channel.
 42. The device of claim 36, whereinthe tongue shield aspirator mates with the bite member in anon-rotational, non-pivotable manner.
 43. The device of claim 36,wherein a posterior side of the neck includes a longitudinal projectionand the bite member's conduit includes a groove to matingly receive saidprojection so as to prevent rotation of the tongue shield aspirator. 44.The device of claim 36, wherein the evacuation tube is approximatelyL-shaped such that, when coupled to the bite member, it exists thepatient's mouth at said oblique angle and then bends posteriorly at anangle of between about 85° and about 110°.
 45. The device of claim 36,further including a locking mechanism to detachably secure theevacuation tube to the bite member.
 46. The device of claim 36, saidtongue shield aspirator being an open tongue shield aspirator.
 47. Thedevice of claim 46, wherein said passageway has a distal end thatcoincides with the second layer's distal edge and is configured to bedirectly exposed to the patient's oral cavity.